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The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological procedures.

The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic electrosurgical procedures.

The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological and hysteroscopic electrosurgical procedures.

Indications for Use in UROLOGY: The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological procedures.

Indications for Use in GYNECOLOGY: The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic hysteroscopic electrosurgical procedures

Indications for Use in UROLOGY and GYNECOLOGY: The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological and hysteroscopic electrosurgical procedures.

Resectoscopes are used for endoscopically controlled ablation of tissue. They are used for examination, diagnosis and/or therapy in conjunction with endoscopic accessories in medical disciplines such as Urology and Gynecology. A resectoscope is a combined cystoscope (urology) or hysteroscope (gynecology) and electrosurgical instruments and consists of a sheath, obturator, working element and HF electrode.

This document describes the KARL STORZ Bipolar Resectoscopes with HF cable (K221893). It is important to note that this device is not an AI/ML powered device, therefore, many of the typical acceptance criteria and study details related to AI performance, such as sample sizes for test and training sets, expert qualifications, and adjudication methods, are not applicable.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a traditional medical device and not an AI/ML powered device, the "acceptance criteria" are based on compliance with recognized standards and design specifications, rather than quantitative performance metrics like sensitivity or specificity.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable for a non-AI/ML medical device. Testing was primarily bench testing to verify engineering specifications and compliance with standards. There is no "test set" in the context of image or data analysis.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth, in the context of AI, refers to expert-labeled data. For this device, "ground truth" would be established by engineering specifications and objective measurements against those specifications.

4. Adjudication Method

Not applicable. This is relevant for studies involving human interpretation or labeling of data, which is not the case here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This a traditional medical device, not an AI-assisted device, therefore, no such study was conducted to evaluate human reader improvement with AI.

6. Standalone Performance Study

Yes, in a sense. The non-clinical performance data (electrical safety, biocompatibility, and various performance tests) represent the "standalone" performance of the device without human interaction being a variable in the performance assessment itself (though human surgeons use the device). The tests verify the device's inherent functional characteristics and safety.

7. Type of Ground Truth Used

For non-clinical testing of a traditional medical device, the "ground truth" used would be:

• Engineering Specifications: Pre-defined technical requirements for the device's dimensions, material properties, electrical characteristics, mechanical strength, and functional performance.
• Recognized Standards: International (e.g., IEC, ISO) and national standards that set minimum safety and performance requirements for medical devices of this type.
• Comparative Performance to Predicate Device: The performance of the legally marketed predicate device (K210651), which serves as a benchmark for substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This device does not involve machine learning; therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for a machine learning model, establishing ground truth for such a set is irrelevant.

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The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas via suction channel under continuous flow conditions following resection using a bipolar resecting device.

The Veloxion System consists of the following components:

• Veloxion Controller (with Integrated Fluid Control and video)
  • Footswitch
• Veloxion Resectoscope
• Veloxion Fluid Control Set
• Veloxion Roll Stand

The Veloxion System also includes the following Class I accessories for handling of waste collected from the patient (these items only handle waste after it is already outside the patient), which includes:

• Waste Management Tubing: To provide a conduit for transfer of aspirated fluids and tissue from the patient and from under the patient's buttocks drape
• Tissue Catch: For collection of gross resected tissue pieces for pathology.

The Veloxion System provides bipolar resection and coagulation of prostate adenomas, it distends the cavity by filling with saline and it provides pressure control of the cavity to facilitate viewing with the integrated Resectoscope.

The provided text describes a 510(k) premarket notification for the Veloxion System, a medical device used for prostate adenoma resection. The document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria based on a clinical study of its diagnostic or therapeutic efficacy.

Therefore, many of the requested details regarding acceptance criteria for device performance (e.g., sensitivity, specificity, or effect size of human reader improvement with AI) and a study proving the device meets these criteria are not present in this regulatory submission document. This document is instead a technical comparison and non-clinical testing summary to assert device safety and effectiveness.

However, I can extract information related to the technical specifications and performance testing conducted to demonstrate substantial equivalence, which serves as the "acceptance criteria" for this type of regulatory submission.

Here's the closest interpretation of your request based on the provided text:

Acceptance Criteria and Device Performance (Based on Technical Specifications and Non-Clinical Testing for Substantial Equivalence)

Study Proving the Device Meets the Acceptance Criteria:

The document describes non-clinical testing rather than a traditional clinical study with patient outcomes or reader performance data. The "study" here refers to a battery of engineering and bench tests designed to demonstrate that the small changes in the new Veloxion System (subject device) do not alter its safety or effectiveness compared to the previously cleared Veloxion System (predicate device).

Here's a breakdown of details relevant to your questions, adapted to the context of this 510(k) submission:

1. Sample sizes used for the test set and the data provenance:

   • The document does not specify sample sizes for individual non-clinical tests (e.g., number of units tested for durability, or number of simulated uses). This information is typically detailed in the full test reports, not summarized in the 510(k) summary letter.
   • Data Provenance: The data is generated from non-clinical performance testing conducted by the manufacturer, Corinth MedTech, Inc. The location of the testing is not specified, but it would typically be conducted at the manufacturer's facilities or a qualified testing lab. The nature is retrospective in the sense that these tests were completed before the 510(k) submission, and reported as final results. There is no mention of data from human subjects or real-world clinical use.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This question is not applicable in the context of this 510(k) submission. The "ground truth" for this device's regulatory pathway is established through engineering specifications, validated test methods, and comparison to a predicate device's known performance. There were no human readers or expert consensus required to establish a "ground truth" for diagnostic or analytical performance, as this is not a diagnostic AI device. The tests, like functional testing, biocompatibility, electrical safety, etc., have well-defined pass/fail criteria based on standards and engineering principles.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic imaging or AI devices, where human expert disagreement needs a resolution mechanism for ground truth. In non-clinical performance testing, the results are typically quantitative measurements against predefined specifications, or qualitative observations per a test protocol, which do not usually require a human "adjudication" process like a clinical reading study.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • This is not applicable. The Veloxion System is an electrosurgical device for tissue resection, not an AI-assisted diagnostic tool. No MRMC study or AI assistance evaluation was conducted or is relevant for this type of device.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • This is not applicable. This device is a surgical instrument system, not an AI algorithm. Its function relies on mechanical, electrical, and fluidic principles controlled by the user, not a standalone AI algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • For this device, the "ground truth" for meeting regulatory requirements is primarily based on:
     • Engineering specifications and standards: e.g., electrical safety standards (IEC 60601 series), biocompatibility standards (ISO 10993), sterility standards (ISO 11135), etc.
     • Defined functional performance criteria: for aspects like flow rates, pressure control, temperature limits, tissue cutting/coagulation performance (demonstrated in simulated use), and durability.
     • Comparison to Predicate Device: The ultimate "ground truth" for a 510(k) relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device in terms of safety and effectiveness, based on similar technological characteristics and comparable performance. Any differences (like the cut mode flow rate) must be shown not to raise new questions of safety or effectiveness, which was addressed via performance testing.

7. The sample size for the training set:

   • This is not applicable. There is no "training set" in the context of this device, as it is not an AI/machine learning product.

8. How the ground truth for the training set was established:

   • This is not applicable for the same reason as above. There is no training set mentioned in this context.

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The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas and bladder tumors (TURBT) via suction channel under continuous flow conditions following resection using a bipolar resectoscope.

The Veloxion System consists of the following components:

• Veloxion Controller (with Integrated Fluid Control)
  • Footswitch
• Veloxion Resectoscope
• Veloxion Fluid Control Set
• Veloxion Video Control Unit
• Veloxion Roll Stand

The Veloxion System also includes the following Class I accessories for handling of waste collected from the patient (these items only handle waste after it is already outside the patient), which includes:

• Waste Management Tubing: To provide a conduit for transfer of aspirated fluids and tissue from the patient and from under the patient's buttocks drape
• Tissue Catch: For collection of gross resected tissue pieces for pathology.
• Waste Management Bags: To provide bags for final collection of outflow.

The Veloxion System provides bipolar resection and coagulation of intrauterine tissue, it distends the uterus by filling with saline, it provides pressure control of the intrauterine cavity for insufflation to facilitate viewing with the integrated hysteroscope and it monitors the fluid deficit (potential fluid absorbed by the patient's body) to the physician established limit. The components of Veloxion System perform the following functions:

• The Veloxion Controller provides bipolar radiofrequency outputs (for cut and coagulation) and fluid/pressure control through the use of two integrated peristaltic pumps, provides the user interface to establish the desired set pressure, monitors intracavitary pressure using dual independent pressure sensors mechanically connected to the Veloxion Fluid Control Set irrigation lumen. The software then monitors, controls and notifies the user when the limits are reached or when specific conditions are met.
• The Veloxion Resectoscope is a sterile single use hand held bipolar radiofrequency device configured to provide camera and light for visualization of the anatomy for the resection of tissue and aspiration of resected chips. Fluid inflow and aspiration of the resected chips are controlled by the Controller's peristaltic pumps.
• The Veloxion Fluid Control Set is a sterile single use device that provides conduits for fluid inflow, aspiration of resected tissue and fluids and a diaphragm (pressure membrane) that provides mechanism for the Controller to measure cavity pressure (through the irrigation lumen) during the procedure thereby facilitating the insufflation function.
• The Veloxion Video Control Unit provide control of the camera, light, display image to a commercially available monitor, stores image and video selected by the user from a session, and provides a USB connection for a USB Stick download of stored media by the user.
• The Veloxion Roll Stand enables monitoring of saline remaining in the saline bag and facilitates the fluid deficit function.

This document, a 510(k) Premarket Notification for the Veloxion System, details the device's characteristics and its equivalence to previously cleared predicate devices, allowing it to be marketed. However, it explicitly states, "No new performance testing was required to establish substantially equivalence. Results of tests in reviewed as part of clearance of K190099 and K162979 with comparison testing to the predicates (predicate Veloxion System and Richard Wolf Resectoscope) support substantial equivalence to the identified predicates."

This crucial statement means the provided text does not contain the acceptance criteria or a study that proves the device meets the acceptance criteria directly within this submission. It relies on previous clearances (K190099 and K162979) and their associated testing.

Therefore, many of the requested details about acceptance criteria, specific performance data, sample sizes, ground truth establishment, and expert involvement are not present in this document.

Despite this, I will extract what information is available and clearly indicate where details are missing based on the document's content.

Based on the provided document, specific details regarding the acceptance criteria and a standalone study proving the device meets these criteria are NOT presented. The submission relies on demonstrating substantial equivalence to predicate devices, referencing prior clearances (K190099 and K162979) for performance data.

Here's an analysis of the requested information based on the provided text, highlighting what is present and what is absent:

1. A table of acceptance criteria and the reported device performance

• Not provided in this document. The document states "No new performance testing was required" for this submission, indicating that performance data relies on previous clearances of the Veloxion System (K190099, K162979) and comparative testing against other predicates. This document does not present a table of acceptance criteria or new reported performance data.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided in this document. No new test set is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided in this document. As no new test set or ground truth establishment is described for this submission, this information is not available. This would typically be relevant for studies involving diagnostic or image-based AI, which this device is not.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided in this document. No test set or human adjudication process is described for this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable/Not provided in this document. This device is a surgical system, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant in this context, and no such study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable/Not provided in this document. The Veloxion System is a physical medical device (resectoscope system), not a standalone algorithm or AI. Its performance is tied to its mechanical and electronic functions.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable/Not provided in this document. For a physical device like the Veloxion System, "ground truth" would typically relate to engineering specifications, performance parameters (e.g., fluid flow rates, power output, pressure control accuracy), and safety standards, rather than clinical diagnostic "ground truth" established by experts or pathology. This document does not detail the specific performance testing or the "ground truth" metrics used in prior clearances.

8. The sample size for the training set

• Not applicable/Not provided in this document. The Veloxion System is a hardware device with integrated software for control and monitoring. While software verification testing is mentioned (point below), there's no indication of a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

• Not applicable/Not provided in this document. As above, no "training set" in the machine learning sense is described. The document mentions "Software Verification Testing was performed using the same protocol reviewed as part of K 190099 for all steps affected by the change and documentation updated per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."" This indicates adherence to software validation best practices, but not a machine learning training paradigm.

Summary of what the document does provide:

• Device Name: Veloxion System
• Predicate Devices: K190099, K162979 (both Corinth MedTech, Inc. Veloxion System), K062720, K042523 (Richard Wolf Medical Instruments Corporation systems).
• Indications for Use: The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas and bladder tumors (TURBT) via suction channel under continuous flow conditions following resection using a bipolar resectoscope.
• Technological Characteristics Comparison: A detailed table comparing the subject device's energy type, RF functions, cavity pressure monitoring, irrigation fluid, outer sheath dimensions, electrode extension, and electrode movement to its predicates. Minor differences are noted.
• Performance Data Statement: "No new performance testing was required to establish substantially equivalence. Results of tests in reviewed as part of clearance of K190099 and K162979 with comparison testing to the predicates (predicate Veloxion System and Richard Wolf Resectoscope) support substantial equivalence to the identified predicates."
• Software Verification: Mentions software verification testing was performed using the same protocol as K190099, updated per FDA guidance for software in medical devices.

In essence, this 510(k) submission is a "Special 510(k)" which often means a modification to an already cleared device, and thus relies on demonstration of substantial equivalence rather than entirely new performance studies. The detailed studies proving acceptance criteria were conducted for the original clearances (K190099 and K162979).

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The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas via suction channel under continuous flow conditions following resection using a bipolar resecting device.

The Veloxion System consists of the following components: Veloxion Controller (with Integrated Fluid Control) with Footswitch, Veloxion Resectoscope, Veloxion Fluid Control Set, Veloxion Video Control Unit, and Veloxion Roll Stand. The system also includes Class I accessories for handling waste: Waste Management Tubing and Tissue Catch. The system provides bipolar resection and coagulation of prostate adenomas, distends the cavity by filling with saline, and provides pressure control of the cavity to facilitate viewing with the integrated Resectoscope.

This 510(k) summary for the Veloxion System (K190099) does not include a detailed study with acceptance criteria and reported device performance in the format of a table, nor does it provide a multi-reader multi-case comparative effectiveness study or details on standalone algorithm performance.

However, based on the provided text, here's an attempt to outline the acceptance criteria and study information where available, focusing on what can be inferred or directly stated.

Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of acceptance criteria with specific numerical targets and corresponding reported device performance. Instead, it lists various non-clinical tests performed to demonstrate safety and effectiveness and substantial equivalence to a predicate device. The general acceptance criterion implied across all these tests is that the subject device performs as safely and effectively as the predicate device, or meets relevant industry standards.

Here's a summary of the performance claims based on the non-clinical testing data:

Here's the additional information requested, based on the provided text:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document does not specify sample sizes for any of the non-clinical tests.
• The data provenance (country of origin, retrospective/prospective) is not provided. All tests listed are non-clinical, implying laboratory or simulated environments, rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not provided. No clinical studies are described, therefore "ground truth" in the clinical sense (e.g., from expert diagnoses) is not applicable here. The "ground truth" for the non-clinical tests would be the established engineering and medical standards and functional specifications that the device is tested against.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not provided and is not applicable to the non-clinical testing described. Adjudication methods are typically associated with clinical studies involving human observers or diagnoses.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. This device is an active medical device (resectoscope system) for prostate adenoma resection, not an AI-powered diagnostic or assistive tool for image interpretation by human radiologists/clinicians in the sense that MRMC studies typically evaluate. The "visualization testing in a simulated model" is the closest mentioned, but it's not an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This device is not an algorithm or AI system in the typical standalone sense. It's a surgical system with integrated software and controls. While software verification and validation were performed (per IEC 62304), this refers to the performance of the integrated software controlling the device's functions, not a standalone AI algorithm producing diagnostic or predictive outputs.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the non-clinical tests, the "ground truth" would be objective measurements against established technical specifications, engineering principles, and relevant international and national standards (e.g., ISO, IEC, ASTM standards mentioned in the text). For fluid flow, pressure control, temperature, electrical safety, durability, and biocompatibility, the ground truth is the scientific and engineering benchmarks and standards themselves. For "simulated use" and "comparative visualization," the "ground truth" would involve demonstrating the device's ability to achieve its intended function effectively within the simulated environment, comparable to the predicate.

8. The sample size for the training set

• This information is not applicable. The Veloxion System is a physical medical device with integrated software for control, not a machine learning or AI model that requires a "training set" to learn from data.

9. How the ground truth for the training set was established

• This information is not applicable for the reasons stated in point 8.

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The Veloxion System is intended for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas via suction channel under continuous flow conditions following resection using a bipolar resecting device.

The Veloxion System consists of the following components:

• Veloxion Controller (with Integrated Fluid Control)
  • o Footswitch
• Veloxion Resecting Device Kit: ●
  • o Veloxion Resecting Device
  • o Sheath
  • 0 Continuous Flow Optical Obturator
• Veloxion Fluid Control Set ●
• Veloxion Saline Pole ●

The Controller provides bipolar radiofrequency outputs (cut and coagulation) and fluid control through the use of two integrated peristaltic pumps. The Resecting Device is a disposable, hand held bipolar radiofrequency device configured for the resection and aspiration of resected chips. Fluid inflow and aspiration of the resected chips are controlled by the Controller's peristaltic pumps, in conjunction with the disposable Fluid Control Set, which provides continuous inflow and aspiration during the procedure.

The provided text is a 510(k) premarket notification from the FDA, and it describes a medical device called the "Veloxion System" for endoscopically controlled tissue chip resection and coagulation, specifically for prostate adenomas.

However, it does not contain any information regarding acceptance criteria, device performance metrics, or study details (like sample size, number of experts, ground truth, or MRMC studies) related to the clinical performance or efficacy of the device.

The "Performance Data" section (VII) lists various types of engineering and safety tests (e.g., Sterility, Biocompatibility, Software, EMC, Mechanical Integrity, Functional Testing, Dimensional Testing, Simulated Use, Thermal effect, Usability). These are primarily focused on the device's technical specifications, safety, and manufacturing quality, rather than its clinical efficacy or diagnostic accuracy.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document does not contain this type of information.

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Resectoscopes are used for endoscopically controlled ablation of tissue. They are used for examination, diagnosis and/or therapy in conjunction with endoscopic accessories in the various medical disciplines such as Urology and Gynecology.

Resectoscopes are used in transuretheral resection of the prostate (TURP) and in transuretheral resection of bladder tumors (TURB). They consist of:

• · Endoscope
• · Resectoscope sheaths with obturators
• · Working Element
• · Electrodes
  The devices are reusable and provided nonsterile. They must be cleaned and sterilized before use.
  The body contact materials are surgical grade stainless steel which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

The provided text is a 510(k) summary for the AED Resectoscope, and it does not contain the detailed information typically found in a study proving a device meets acceptance criteria. This document focuses on demonstrating substantial equivalence to predicate devices, rather than independent performance studies with specific acceptance criteria and detailed statistical analysis.

Therefore, many of the requested fields cannot be filled from the given text.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The document describes a "design analysis and comparison" rather than a clinical or performance test set involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Not provided. Ground truth establishment is typically for diagnostic devices or those requiring expert interpretation. This device is a surgical instrument. The evaluation here is against engineering standards and comparison to predicate devices, not against a "ground truth" established by experts in a clinical scenario.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not provided. This relates to clinical studies with expert reviewers, which is not the type of evaluation described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a resectoscope, a surgical instrument, not an AI-powered diagnostic tool. MRMC studies are not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical surgical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable. For this type of device, the "truth" is typically adherence to engineering specifications, safety standards, and functional equivalence to legally marketed predicate devices, not a clinical "ground truth" derived from patient outcomes or pathology.

8. The sample size for the training set

• Not applicable. This relates to machine learning models, which are not involved here.

9. How the ground truth for the training set was established

• Not applicable. (See point 8).

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S(a)line Resectoscopes are used for endoscopically controlled removal (ablation) of tissue using 0.9% NaCl solution (saline) as the irrigation medium.

For Urology:
Urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required.
Transurethral resection of the prostate (TURP) and bladder neck. Transurethral resection of the bladder tumors (TURBT). Transurethral incision of the prostate. Coagulation of bleeding in the lower urinary tract.

For Gynecology:
Tissue cutting, removal, and desiccation as required or encountered in gynecologic hystroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, septa, and benign conditions requiring endometrial ablation.
Excision of intrauterine myomas. Excision of intrauterine polyps. Lysis of intrauterine septa. Endometrial ablation.

The bipolar S-line Resectoscopes with electrodes have a design similar to the traditional monopolar resectoscopes, but with an additional pin for the neutral pole at the working element. The HF bipolar connection cables have a standard resectoscope connector and in addition a neutral connection to the neutral pin at the neutral pin at the S-line working element and on unit side plugs for connection to bipolar generators.

The provided 510(k) summary for the "S-line" Saline Bipolar Resectoscope does not contain detailed information about specific acceptance criteria or a study designed to prove the device meets those criteria in the way a diagnostic AI/ML device submission would. Instead, the submission relies on demonstrating substantial equivalence to predicate devices and states that no performance standards are known and no clinical tests were performed for this specific submission.

However, based on the information provided, we can infer the overarching "acceptance criteria" through the lens of safety and effectiveness, and how the submitter "proved" this through substantial equivalence.

Here's an analysis based on your requested categories:

Acceptance Criteria and Device Performance

Since no specific quantitative performance metrics are provided (e.g., sensitivity, specificity, accuracy), the "acceptance criteria" are implied to be that the device functions safely and effectively for its intended use, comparable to its predicate devices.

Study Details (or lack thereof, in an AI/ML context)

1. Sample size used for the test set and the data provenance:

   • Test set size: Not applicable. No dedicated "test set" in the context of an AI/ML performance study was used. The submission relies on technical characteristics and substantial equivalence, not data from a specific test set.
   • Data provenance: Not applicable. No clinical data provided.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. No ground truth establishment in the customary sense for evaluating a diagnostic device's performance.

3. Adjudication method for the test set:

   • Not applicable. No test set or adjudication performed.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This device is a surgical instrument, not an AI/ML diagnostic aid for human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a surgical resectoscope, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable. Ground truth for performance metrics was not established as part of this submission. The "truth" is based on the design and intended function being safe and effective, similar to predicate devices.

7. The sample size for the training set:

   • Not applicable. This device is a hardware instrument, not a learned algorithm.

8. How the ground truth for the training set was established:

   • Not applicable.

Summary of the "Study" provided in Ko62720:

The submission for K062720 does not describe a "study" in the typical sense of a clinical trial or performance evaluation for an AI/ML device. Instead, it follows a 510(k) pathway for medical devices which primarily relies on demonstrating substantial equivalence to already legally marketed predicate devices.

The arguments made are:

• Technological Characteristics: The device has a similar design to traditional monopolar resectoscopes but includes an additional pin for the neutral pole, enabling bipolar functionality. It highlights the benefits of using saline over Purisole/Glycine solution (minimizing TUR-syndrome) and avoids intra-operative muscle tremor due to current localization.
• Safety and Effectiveness: The conclusion states that the devices are "designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual." This suggests manufacturing controls and design verification/validation (which are typically part of a Quality System) rather than a specific clinical performance study for regulatory submission.
• Predicate Devices: Substantial equivalence is claimed to several predicate devices, including resectoscopes from Richard Wolf (K980302, K042523), Olympus, ACMI (K031001, K022480), and a Gyrus system. The device's safety and effectiveness are considered to be comparable to these established devices, with the new technological characteristics not diminishing safety or effectiveness.
• No specific performance standards or clinical tests were performed for this submission.

In essence, the "proof" the device meets acceptance criteria is derived from its design, its intended function, and its demonstrated similarity (substantial equivalence) to devices already on the market where safety and effectiveness have been previously established.

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The Resection Pump 2228 with Resectoscope 8659.xxx is used for endoscopically controlled tissue chip resection and removal of intrauterine polyps, intrauterine myomas or prostate adenomas via suction channel under continuous flow conditions following resection using a high-frequency electrode with a resectoscope.

The Resection Pump 2228 is used in combination with a large diameter resectoscope to suction off tissue chips by a short pulse vacuum after the removal with a high-frequency electrode. The complete procedure is done under endoscopic view and continuous flow conditions. The airflow of the control tube is interrupted when the grip of the working element is in the end position and the tissue is cut. This results in a change in pressure which triggers the resection pump to open the tube clamp valve for a short period of time. This generates a brief vacuum pressure via the secretion trap and the tissue chip is sucked off and collected in the chip fluid trap. The resection pump 2228 is software controlled. Key functions and components are automatically monitored to ensure safe operation. If there is a fault, a message is shown on the LCD display in conjunction with an acoustic signal.

The provided documents describe the Resection Pump 2228, a medical device for tissue chip resection and removal. However, the information regarding "acceptance criteria" and the "study that proves the device meets the acceptance criteria" is limited from the perspective of an AI-based device's performance metrics and clinical studies.

Based on the provided text, the device's performance is primarily established through design to standards and lack of clinical tests. The submission is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting new clinical trials to establish efficacy unique to this device.

Here's an analysis based on your requested categories, acknowledging the limitations of the provided text:

1. A table of acceptance criteria and the reported device performance

Study Proving Acceptance Criteria:

The document explicitly states: "No clinical tests performed."

The "study" proving the device meets its acceptance criteria is primarily based on technical design, adherence to recognized safety standards, and a demonstration of substantial equivalence to already legally marketed predicate devices. This is typical for a 510(k) premarket notification. The FDA's acceptance is based on the review of the submitted documentation, including product specifications, design principles, and comparison to predicates, rather than new clinical trials.

2. Sample size used for the test set and the data provenance:

• Sample size: Not applicable, as no clinical tests or specific "test sets" for performance evaluation (in the AI/clinical study sense) were performed.
• Data provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable, as no clinical tests were performed, and thus no "ground truth" was established through expert review for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is not an AI-assisted diagnostic or interpretive tool, but a mechanical pump.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is not an algorithm; it's a physical pump that operates with human interaction (endoscopic view, high-frequency electrode).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable in the context of clinical performance data for this submission. The "ground truth" for the 510(k) submission is the functional and safety specifications of the device, proven by engineering design, internal testing (not detailed), and compliance with standards, establishing substantial equivalence to predicates.

8. The sample size for the training set:

• Not applicable for this type of device. There is no "training set" in the context of an AI/machine learning model.

9. How the ground truth for the training set was established:

• Not applicable for this type of device.

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Morce Scope Set 8970:
The Morce Scope Set, in conjunction with a morcellation probe, and with its sheaths and obturators, is used in the cutting (morcellation) and continuous removal of large detached tissue masses.
In combination with intracorporeal lithotriptors, e.g. operated pneumatically, by ultrasound, electro-hydraulically or by laser under endoscopic control, it can be used as a nephroscope in the disintegration and removal/aspiration of kidney and bladder stones and the removal of detached tumors from the bladder.

Power Control 2303:
The POWER CONTROL 2303 in conjunction with POWER STICK M4 serves to drive WOLF morcellators for the continuous removal of ablated tissue in endoscopic operations.

Suction Pump 2207:
The SUCTION PUMP is used for aspirating irrigation fluid in conjunction with a resectoscope or a morcellator following laser TURP.

Indication and Field of Use:
When used as a Morce Scope: for therapy via the transurethral passage after a TURP (TransUrethral Resection of the Prostate) procedure.
When used as a nephroscope: for diagnosis and therapy of urolithiasis.
In both cases the product must be used in conjunction with endoscopic accessories. The product may only be applied by adequately qualified and trained medical personnel.

The Morce Scope Set 8970, is a morcellation set that consist of a Morce endoscope, rotary blade, sheaths, obturators and an optional sieve. The rotary blade is designed to be inserted through the Morce endoscope, requiring one incision. The rotary blades are driven by the motor on the Power Controlled by the Power Control Generator 2303. The suction pump 2207 removes the morcellated tissue.

This is a 510(k) premarket notification for a medical device (Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207), not an AI/ML device, and therefore the provided document does not contain information on acceptance criteria or a study proving that an AI/ML device meets those criteria. The information requested (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is specific to AI/ML device evaluations and is not relevant to this traditional medical device submission.

The document indicates that "No clinical tests performed" were conducted for this device. The performance data section states that "The devices are designed to meet the standards IEC601-11 1988 and A1 + A2 and IEC601-1-2." This refers to electrical safety and electromagnetic compatibility standards, not to clinical performance or accuracy in the context of AI/ML.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the other questions as they pertain to AI/ML device studies.

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